Definition of Autonomic Nervous System Involvement in Patients With Relapsing-remitting and Primary Progressive Multiple Sclerosis

RecruitingNot a drug-phase studyRelapsing and progressiveNCT05748015

What it found

Still running

No result yet.

What was tested

Treatment tested

  • quantification of sensory and autonomic small nerve fibers by punch skin biopsy
  • Cardiovascular Reflexes testing
  • Administration of clinical scales evaluating autonomic symptoms, pain small fiber neuropathy symptoms

What it measured

Main measures

  • Cardiovascular reflex test

    At the recruitment

  • Sudomotor function test

    At the recruitment

Other measures (2)

  • Quantification of peripheral autonomic nerve fibers

    At the recruitment

  • Quantification of peripheral sensory nerve fibers

    At the recruitment

Who could take part

Relapsing and progressive · 18 and over

Show the full criteria

Inclusion criteria

* diagnosis of relapsing-remitting and primary progressive multiple sclerosis.

Exclusion criteria

* other forms of multiple sclerosis, * known other neurological disorders * assumption of potentially neurotoxic substances or drugs.

As registered. Criteria can change, so ask the trial team or your neurologist.

Contact details on the registry

About this trial

In the sponsor's words

The goal of this interventional non-pharmacological study is to evaluate the involvement of the autonomic nervous system in patients with relapsing-remitting and primary progressive multiple sclerosis. The main questions it aims to answer are: * Is it possible to define the characteristics of dysautonomia to improve treatment on patients with multiple sclerosis through the management of conditions such as orthostatic hypotension or thermoregulation disorders that inevitably condition the patient's life and the response to rehabilitation ? * Does the severity of the functional alterations correlate with impairment of small somatic and autonomic cutaneous nerve fibers in patients with multiple sclerosis ? * How much the involvement of the autonomic nervous system affects the clinical history and progression of the disease ? * Do different clinical variants of multiple sclerosis manifest with different patterns of involvement of the sensory-autonomic nervous system ? Participants will be hospitalized in Maugeri Clinical Institute of Telese Terme for a rehabilitation treatment. Patients will perform a sensory and autonomic functional study and a morphological analysis of cutaneous nerves through skin biopsy. Researchers will compare results between the two groups (relapsing-remitting and primary progressive) and between patients and data from control subjects.

Papers

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History

    1. Started

      Mar 2021

    2. Main results due

      Nov 2026

    3. Finished

      May 2027

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